510(k) · Cleared
ClearedFEops HEARTguideTM, FEops HEARTguideTM ALPACA
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Feops NV · QIH Automated Radiological Image Processing Software
Cleared on Jun 6, 2023 as substantially equivalent to K153736 (Pie Medical Imaging BV, 2016) after a 165-day review. Its family tree reaches back 7 generations to 1996.
- Decided
- Jun 6, 2023
- Review
- 165 days
- Class
- Class II
- Product code
- QIH
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 7 generations to K954678 (1996). 19 ancestors in all, the oldest K954668 (1995). No later device cites it as a predicate yet.
- Root · 7 generations backK954678 Pro VisionAlgotec Systems, Ltd. · 1996
- 6 generations backK980648 Pro VisionAlgotec Systems, Ltd. · 1998
- 5 generations backK992654 Plug 'N View 3D, Version 1.0Voxar Limited · 1999
- 4 generations backK043097 3VISEON3Mensio Medical Imaging BV · 2004
- 3 generations backK072653 3VISEON/Surgery3Mensio Medical Imaging BV · 2008
- 2 generations backK120367 3MENSIO WorkstationPie Medical Imaging BV · 2012
- 1 generation backK153736 3mensio WorkstationPie Medical Imaging BV · 2016 · Recalled
- This deviceK223855 FEops HEARTguideTM, FEops HEARTguideTM ALPACAFeops NV · 2023
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K954678 | Pro Vision | Algotec Systems, Ltd. | 1996 | — |
| −6 | K980648 | Pro Vision | Algotec Systems, Ltd. | 1998 | — |
| −5 | K992654 | Plug 'N View 3D, Version 1.0 | Voxar Limited | 1999 | — |
| −4 | K043097 | 3VISEON | 3Mensio Medical Imaging BV | 2004 | — |
| −3 | K072653 | 3VISEON/Surgery | 3Mensio Medical Imaging BV | 2008 | — |
| −2 | K120367 | 3MENSIO Workstation | Pie Medical Imaging BV | 2012 | — |
| −1 | K153736 | 3mensio Workstation | Pie Medical Imaging BV | 2016 | 1 |
| 0 (this device) | K223855 | FEops HEARTguideTM, FEops HEARTguideTM ALPACA | Feops NV | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 1 | 0 |
| 1996 | 2 | 0 |
| 1997 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
| 2004 | 2 | 0 |
| 2006 | 2 | 0 |
| 2015 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in QIH? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new QIH device
- #1 K213998 cvi42 Auto Imaging Software Applicationscore 23.5 · 7 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K153736 | 3mensio WorkstationSummary page 4…nsio Workstation/3mensio Structural Heart/3mensio Vascular 510(k) number: K153736 Decision date May 27, 2016 Classification product code LLZ Regul… | 2016 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 27 years and passes through 5 companies; a new generation was cleared every 4.1 years on median.
- 5 of the 19 ancestors have a recall of any class.
- 10 other devices also cite its predicate K153736.
How does its category compare?
All QIH devicesQIH Automated Radiological Image Processing Software: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, this device’s year, is highlighted.
FDA decisions per year · QIH
94in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · QIH
150in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · QIH
1so far in 2026, the most since 2007
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · QIH
4in 2025
MAUDE reports naming product code QIH, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 2 | — | 0 | 0 |
| 2020 | 11 | 145 | 0 | 0 |
| 2021 | 19 | 125 | 0 | 0 |
| 2022 | 25 | 134 | 0 | 0 |
| 2023 | 45 | 151 | 0 | 0 |
| 2024 | 64 | 141 | 0 | 2 |
| 2025 | 94 | 150 | 0 | 4 |
| 2026 | 78 | 130 | 1 | — |
What is it indicated for?
FEops HEARTguide™ ALPACA enables visualization and measurement of structures of the heart and vessels for preprocedural planning and sizing of structural heart interventions. To facilitate the above, FEops HEARTguide™ ALPACA provides general functionality such as: • Segmentation of cardiovascular structures • Visualization and image reconstruction techniques: 2D review, MPR • Measurement and annotation tools • Reporting tools FEops HEARTguide™ ALPACA…
Read the full statement (131 words)
FEops HEARTguide™ ALPACA enables visualization and measurement of structures of the heart and vessels for
preprocedural planning and sizing of structural heart interventions.
To facilitate the above, FEops HEARTguide™ ALPACA provides general functionality such as:
• Segmentation of cardiovascular structures
• Visualization and image reconstruction techniques: 2D review, MPR
• Measurement and annotation tools
• Reporting tools
FEops HEARTguide™ ALPACA also allows visualization of output generated by other medical device software (e.g., FEops HEARTguide™ Simulation Application cleared as K214066).
The results are intended to be used by qualified clinicians in conjunction with the patient's clinical history, symptoms, and other preprocedural evaluations, as well as the clinician's professional judgment.
FEops HEARTguide™ ALPACA is not intended to replace the implant device instructions for use for final LAAO and TAVI device selection and placement.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K223855 · printed Nov 6, 2026
Cite this page
510(k) Report. “K223855: FEops HEARTguideTM, FEops HEARTguideTM ALPACA.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K223855
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026